FDA UDI
In Commercial Distribution
🇺🇸 United States
SureClip
DI: 06932503530385
·
Model: ROCC-F-26-235-C-R
·
Micro-Tech (Nanjing) Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- SureClip
- Primary DI
- 06932503530385
- Version / Model
- ROCC-F-26-235-C-R
- Catalog Number
- ROCC-F-26-235-C-R
- Company Name
- Micro-Tech (Nanjing) Co., Ltd.
- Labeler DUNS
- 530269083
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-21
- Public Version
- 4
- Public Version Date
- 2021-05-13
- Public Version Status
- Update
- Public Device Record Key
- e940d43e-30f5-4a17-a6c8-995d6303c0b7
Device Description
Open width16±2mm the max OD of insertion part 2.6mm working length 2350mm coated, single rotation wire
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PKL | Hemostatic Metal Clip For The Gi Tract | Gastroenterology, Urology | 876.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61208 | Gastrointestinal endoscopic clip, long-term, non-bioabsorbable | A non-bioabsorbable clip intended to be implanted long-term (>30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, treating mucosal/submucosal defects, and/or as part of bariatric procedures. It is a metallic device with a clasping mechanism; a disposable applicator may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 26932503530389 | GS1 | case | 10 | In Commercial Distribution | |
| Package | 16932503530382 | GS1 | box | 10 | In Commercial Distribution | |
| Primary | 06932503530385 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152001 | 000 |